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Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial

INTRODUCTION: Treatment options for adults with attention deficit hyperactivity disorder (ADHD) are limited. The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release (MPH-LA) in adults with ADHD and evaluate the maintenance of effect...

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Autores principales: Huss, Michael, Ginsberg, Ylva, Tvedten, Torbjorn, Arngrim, Torben, Philipsen, Alexandra, Carter, Katherine, Chen, Chien-Wei, Kumar, Vinod
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905180/
https://www.ncbi.nlm.nih.gov/pubmed/24371021
http://dx.doi.org/10.1007/s12325-013-0085-5
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author Huss, Michael
Ginsberg, Ylva
Tvedten, Torbjorn
Arngrim, Torben
Philipsen, Alexandra
Carter, Katherine
Chen, Chien-Wei
Kumar, Vinod
author_facet Huss, Michael
Ginsberg, Ylva
Tvedten, Torbjorn
Arngrim, Torben
Philipsen, Alexandra
Carter, Katherine
Chen, Chien-Wei
Kumar, Vinod
author_sort Huss, Michael
collection PubMed
description INTRODUCTION: Treatment options for adults with attention deficit hyperactivity disorder (ADHD) are limited. The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release (MPH-LA) in adults with ADHD and evaluate the maintenance of effect of MPH-LA. METHODS: The study consisted of three treatment phases. The double-blind dose-confirmation phase: 9-week double-blind period (3-week titration period, 6-week fixed dose) with randomization to MPH-LA 40, 60, or 80 mg/day or placebo. The real-life dose-optimization phase: a 5-week re-titration period to optimal dose; and the double-blind maintenance of effect phase, a 6-month double-blind randomized placebo-controlled maintenance of effect phase. The three co-primary endpoints were change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores from baseline to end of 9-week confirmation phase and the percentage of treatment failures during the 6-month maintenance of effect phase. RESULTS: 725 of 863 screened patients were randomized to 40 (N = 181), 60 (N = 182), or 80 mg (N = 181) MPH-LA or placebo (N = 181), and 584 (80.6%) completed. 489 (83.7%) of completers were re-randomized to the double-blinded maintenance of effect phase and 235 (48.1%) of them completed. Improvement from baseline in DSM-IV ADHD RS (P < 0.0001 for all comparisons) and SDS (40 mg, P = 0.0003; 60 mg, P = 0.0176; 80 mg, P < 0.0001) total scores was significantly greater vs. placebo for all MPH-LA doses. Treatment failure rate was significantly lower with MPH-LA (21.3%) versus placebo (49.6%) during the 6-month maintenance of effect phase. Safety profile was consistent with the profile for MPH-LA in children; percentage of serious adverse events was comparable between all MPH-LA arms (1.3%) and placebo (1.5%), while percentage of adverse events was higher in MPH-LA arms. CONCLUSION: MPH-LA provided and maintained significant symptomatic and functional improvement in adult ADHD patients. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-013-0085-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-39051802014-01-30 Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial Huss, Michael Ginsberg, Ylva Tvedten, Torbjorn Arngrim, Torben Philipsen, Alexandra Carter, Katherine Chen, Chien-Wei Kumar, Vinod Adv Ther Original Research INTRODUCTION: Treatment options for adults with attention deficit hyperactivity disorder (ADHD) are limited. The study was conducted to confirm the clinically effective and safe dose of methylphenidate hydrochloride modified-release (MPH-LA) in adults with ADHD and evaluate the maintenance of effect of MPH-LA. METHODS: The study consisted of three treatment phases. The double-blind dose-confirmation phase: 9-week double-blind period (3-week titration period, 6-week fixed dose) with randomization to MPH-LA 40, 60, or 80 mg/day or placebo. The real-life dose-optimization phase: a 5-week re-titration period to optimal dose; and the double-blind maintenance of effect phase, a 6-month double-blind randomized placebo-controlled maintenance of effect phase. The three co-primary endpoints were change in Diagnostic and Statistical Manual of Mental Disorders-IV ADHD Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores from baseline to end of 9-week confirmation phase and the percentage of treatment failures during the 6-month maintenance of effect phase. RESULTS: 725 of 863 screened patients were randomized to 40 (N = 181), 60 (N = 182), or 80 mg (N = 181) MPH-LA or placebo (N = 181), and 584 (80.6%) completed. 489 (83.7%) of completers were re-randomized to the double-blinded maintenance of effect phase and 235 (48.1%) of them completed. Improvement from baseline in DSM-IV ADHD RS (P < 0.0001 for all comparisons) and SDS (40 mg, P = 0.0003; 60 mg, P = 0.0176; 80 mg, P < 0.0001) total scores was significantly greater vs. placebo for all MPH-LA doses. Treatment failure rate was significantly lower with MPH-LA (21.3%) versus placebo (49.6%) during the 6-month maintenance of effect phase. Safety profile was consistent with the profile for MPH-LA in children; percentage of serious adverse events was comparable between all MPH-LA arms (1.3%) and placebo (1.5%), while percentage of adverse events was higher in MPH-LA arms. CONCLUSION: MPH-LA provided and maintained significant symptomatic and functional improvement in adult ADHD patients. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-013-0085-5) contains supplementary material, which is available to authorized users. Springer Healthcare 2013-12-27 2014 /pmc/articles/PMC3905180/ /pubmed/24371021 http://dx.doi.org/10.1007/s12325-013-0085-5 Text en © The Author(s) 2013 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Research
Huss, Michael
Ginsberg, Ylva
Tvedten, Torbjorn
Arngrim, Torben
Philipsen, Alexandra
Carter, Katherine
Chen, Chien-Wei
Kumar, Vinod
Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial
title Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial
title_full Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial
title_fullStr Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial
title_full_unstemmed Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial
title_short Methylphenidate Hydrochloride Modified-Release in Adults with Attention Deficit Hyperactivity Disorder: A Randomized Double-Blind Placebo-Controlled Trial
title_sort methylphenidate hydrochloride modified-release in adults with attention deficit hyperactivity disorder: a randomized double-blind placebo-controlled trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905180/
https://www.ncbi.nlm.nih.gov/pubmed/24371021
http://dx.doi.org/10.1007/s12325-013-0085-5
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